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

Report

• Report Number: 1020279-2026-00554
• Event Type: Injury
• Date Received: April 27, 2026
• Report Date: April 27, 2026
• Manufacturer: SMITH & NEPHEW, INC.
• Product Code: LZO
• Adverse Event: Yes
• Report Source: Manufacturer report
• Reporter Location: AS
• Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

REPORTING QUARTER: 1 (JANUARY 1ST TO MARCH 31ST) 2026. SUMMARY OF ADVERSE EVENTS: BASED ON REAL WORLD DATA FROM THE AUSTRALIA ORTHOPEDIC ASSOCIATION NATIONAL JOINT REPLACEMENT REGISTRY (AOANJRR), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN AUSTRALIA FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN HIP ARTHROPLASTY: 1. PRIMARY TOTAL HIP ARTHROPLASTY: - BIOLOX DELTA CERAMIC FEMORAL HEAD: A TOTAL OF TEN THOUSAND FIVE HUNDRED AND SIXTY-THREE (10,563) HIPS UNDERWENT PRIMARY THR BETWEEN 01-FEB-2006 AND 20-AUG-2025 IN WHICH A BIOLOX DELTA CERAMIC FEMORAL HEAD WAS IMPLANTED. OF THESE, THREE HUNDRED AND EIGHTY-TWO (382) HIPS REQUIRED REVISION DUE TO THE FOLLOWING REASONS: EIGHTY-TWO (82) HIPS DUE TO FRACTURE, SEVENTY (70) HIPS DUE TO LOOSENING, SIXTY-SEVEN (67) HIPS DUE TO INFECTION, SEVENTY-ONE (71) HIPS DUE TO PROSTHESIS DISLOCATION, SIX (6) HIPS DUE TO LYSIS, TWELVE (12) HIPS DUE TO PAIN, NINE (9) HIPS DUE TO INSTABILITY, NINE (9) HIPS DUE TO LEG LENGTH DISCREPANCY, FOURTEEN (14) HIPS DUE TO MALPOSITION, EIGHT (8) HIPS DUE TO IMPLANT BREAKAGE STEM, SIX (6) HIPS DUE TO METAL RELATED PATHOLOGY, THREE (3) HIPS DUE TO WEAR OF ACETABULAR INSERT, THREE (3) HIPS DUE TO IMPLANT BREAKAGE ACETABULAR INSERT, ONE (1) HIP DUE TO IMPLANT BREAKAGE ACETABULAR, THREE (3) HIPS DUE TO INCORRECT SIZING, TEN (10) HIPS DUE TO WEAR HEAD, ONE (1) HIP DUE TO TUMOUR, AND SEVEN (7) HIPS DUE TO OTHER REASONS. - OXINIUM FEMORAL HEAD: A TOTAL OF FORTY-EIGHT THOUSAND THREE HUNDRED AND FIFTY-THREE (48,353) HIPS UNDERWENT PRIMARY THR BETWEEN 21-JAN-2003 AND 02 DEC-2025 IN WHICH AN OXINIUM FEMORAL HEAD WAS IMPLANTED. OF THESE, A TOTAL OF ONE THOUSAND SIX HUNDRED AND EIGHTY-FIVE (1,685) HIPS REQUIRED REVISION SURGERY. THIS TOTAL INCLUDES IMPLANTS APPROVED FOR USE IN THE UNITED STATES UNDER FDA PRODUCT CODES JDI AND LZO. OF THE ONE THOUSAND SIX HUNDRED AND EIGHTY-FIVE (1,685) REVISION SURGERIES REPORTED FOR THESE IMPLANTS, NINE HUNDRED AND FOUR (904) REVISIONS WERE ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED AN OXINIUM FEMORAL HEAD APPROVED UNDER FDA PRODUCT CODE LZO. THE AOANJRR REPORT PROVIDES THE COMPLETE LIST OF REASONS FOR REVISION FOR ALL 1,685 REVISION CASES BUT DOES NOT DISTINGUISH WHICH REASONS ARE SPECIFICALLY LINKED TO REVISION SURGERIES INVOLVING COMPONENTS APPROVED UNDER FDA PRODUCT CODE LZO. THE REPORTED REASONS FOR REVISION INCLUDE: THREE HUNDRED SEVENTY-ONE (371) DUE TO FRACTURE, TWO HUNDRED SIXTY (260) DUE TO LOOSENING, FOUR HUNDRED ELEVEN (411) DUE TO INFECTION, FOUR HUNDRED THREE (403) DUE TO PROSTHESIS DISLOCATION, THIRTY-TWO (32) DUE TO LYSIS, TWENTY-FOUR (24) DUE TO PAIN, FORTY (40) DUE TO INSTABILITY, TWENTY-NINE (29) DUE TO LEG LENGTH DISCREPANCY, THIRTY-ONE (31) DUE TO MALPOSITION, THIRTEEN (13) DUE TO IMPLANT BREAKAGE STEM, ONE (1) DUE TO METAL RELATED PATHOLOGY, SIXTEEN (16) DUE TO WEAR ACETABULAR INSERT, TWO (2) DUE TO IMPLANT BREAKAGE ACETABULAR INSERT, FOUR (4) DUE TO IMPLANT BREAKAGE ACETABULAR, EIGHT (8) DUE TO INCORRECT SIZING, THREE (3) DUE TO TUMOUR, SIX (6) DUE TO HETEROTOPIC BONE, ONE (1) DUE TO WEAR ACETABULUM, AND THIRTY (30) DUE TO OTHER REASONS. IN CONSIDERATION OF THE ABOVE, THE ANALYSIS CONDUCTED ON THE AOANJRR REGISTRY REPORT ENCOMPASSES ALL 1,685 REVISION SURGERIES REPORTED FOR THIS PRODUCT FAMILY. HOWEVER, THE .CSV FILE SUBMITTED UNDER THE REQUIREMENTS OF RWD2300584 INCLUDES ONLY 904 REVISIONS ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED AN OXINIUM FEMORAL HEAD APPROVED UNDER FDA PRODUCT CODE LZO. DUE TO THE STRUCTURE OF AOANJRR REPORT, IT IS NOT POSSIBLE TO ISOLATE OR ATTRIBUTE SPECIFIC STATISTICAL OUTCOMES OR REASONS FOR REVISION EXCLUSIVELY TO THE SUBSET OF 904 CASES. 2. PRIMARY HIP HEMI-ARTHROPLASTY: - OXINIUM FEMORAL HEAD: A TOTAL OF TWO HUNDRED AND TWENTY-EIGHT (228) HIPS UNDERWENT PRIMARY HIP HEMIARTHROPLASTY BETWEEN 02-SEP-2003 AND 29-OCT-2025 IN WHICH AN OXINIUM FEMORAL HEAD WAS IMPLANTED. OF THESE, A TOTAL OF SEVEN (7) HIPS REQUIRED REVISION DUE TO THE FOLLOWING REASONS: THREE (3) HIPS DUE TO PROSTHESIS DISLOCATION, TWO (2) HIPS DUE TO FRACTURE, ONE (1) HIP DUE TO CHONDROLYSIS/ACETABULAR EROSION, AND ONE (1) HIP DUE TO PAIN. DUE TO THE STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DIRECTLY CORRELATED WITH THE INDIVIDUAL PART NUMBERS REPORTED. AS SUCH, IT IS NOT POSSIBLE TO DETERMINE WHICH SPECIFIC PART NUMBERS WERE ASSOCIATED WITH WHICH SPECIFIC REASONS FOR REVISION. ALTOGETHER, A TOTAL QUANTITY OF 1293 REVISIONS BEEN REPORTED IN THE AUSTRALIA ORTHOPEDIC ASSOCIATION NATIONAL JOINT REPLACEMENT REGISTRY (AOANJRR)FOR THE SMITH+NEPHEW DEVICES REFERENCED IN THIS REPORT. ANALYSIS CONDUCTED: BASED ON THE MOST RECENT SAFETY AND PERFORMANCE EVALUATIONS, THE FEMORAL HEAD SYSTEM PRESENT A FAVORABLE BENEFIT/RISK ASSESSMENT WHEN USED UNDER THE CONDITIONS AND FOR THE PURPOSES INTENDED BY THE MANUFACTURER AND WITH RESPECT TO THE CONTRAINDICATIONS AND PRECAUTIONS FOR USE AND WARNINGS DESCRIBED IN THE INFORMATION MATERIAL SUPPLIED WITH THE DEVICES. THESE SYSTEMS ARE AT LEAST AS SAFE AND EFFECTIVE AS ALL ITS THERAPEUTIC ALTERNATIVES IN THE TARGETED INDICATION. THE INTENDED PURPOSE AND INFORMATION FOR SAFETY INCLUDED IN THE INFORMATION MATERIALS SUPPLIED BY THE MANUFACTURER ARE ADEQUATE AND SUITABLE FOR THE INTENDED USES AND USERS. INDUSTRY SUMMARY REPORTS DOCUMENTED BY THE AUSTRALIA ORTHOPEDIC ASSOCIATION NATIONAL JOINT REPLACEMENT REGISTRY (AOANJRR) FOR THE SMITH+NEPHEW PROSTHESES REFERENCED ABOVE IN THE CORRESPONDING ANALYZED HIP ARTHROPLASTY PROCEDURES WERE STUDIED. POST-OPERATIVE OUTCOMES FOR EACH STUDY DEVICE WERE COMPARED AGAINST THOSE OF THE CLASS, DEFINED AS ALL PROSTHESES UTILIZED IN THE CORRESPONDING PROCEDURE TYPE AS RECORDED BY THE AUSTRALIA ORTHOPEDIC ASSOCIATION NATIONAL JOINT REPLACEMENT REGISTRY (AOANJRR). ALL CUMULATIVE REVISION RATES OF EACH RESPECTIVE FEMORAL HEAD VARIANT CAPTURED BY THE AIRS FOR PRIMARY THA AND PRIMARY HIP HEMIARTHROPLASTY PERFORMED IN LINE WITH THE CLASS DEVICE, WHEN CONSIDERING THE CONFIDENCE INTERVALS. BASED ON THE REVIEW OF OTHER CLINICAL SOURCES SUCH AS CLINICAL ACTIVITIES, COMPLAINT DATA, PUBLISHED LITERATURE AND OTHER JOINT REGISTRIES, NO INCREASED RISKS TO HEALTH OR AN INCREASED TREND IN ANY OF THE ADVERSE EVENTS SUMMARIZED ABOVE HAVE BEEN IDENTIFIED. THE REPORTED ADVERSE EVENTS RELATE TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. NO INDIVIDUAL INVESTIGATIONS INTO THE REPORTED ADVERSE EVENTS ARE DEEMED NECESSARY. ADDITIONAL ACTION(S) TAKEN: NO ADDITIONAL ACTIONS ARE DEEMED NECESSARY AT THIS TIME. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED.

Description of Event or Problem · 0

BASED ON REAL WORLD DATA FROM THE AUSTRALIA ORTHOPEDIC ASSOCIATION NATIONAL JOINT REPLACEMENT REGISTRY (AOANJRR), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN THE UNITED KINGDOM FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN HIP ARTHROPLASTY: 1. PRIMARY TOTAL HIP ARTHROPLASTY: - BIOLOX DELTA CERAMIC FEMORAL HEAD: A TOTAL OF TEN THOUSAND FIVE HUNDRED AND SIXTY-THREE (10,563) HIPS UNDERWENT PRIMARY THR BETWEEN 01-FEB-2006 AND 20-AUG-2025 IN WHICH A BIOLOX DELTA CERAMIC FEMORAL HEAD WAS IMPLANTED. OF THESE, THREE HUNDRED AND EIGHTY-TWO (382) HIPS REQUIRED REVISION DUE TO THE FOLLOWING REASONS: EIGHTY-TWO (82) HIPS DUE TO FRACTURE, SEVENTY (70) HIPS DUE TO LOOSENING, SIXTY-SEVEN (67) HIPS DUE TO INFECTION, SEVENTY-ONE (71) HIPS DUE TO PROSTHESIS DISLOCATION, SIX (6) HIPS DUE TO LYSIS, TWELVE (12) HIPS DUE TO PAIN, NINE (9) HIPS DUE TO INSTABILITY, NINE (9) HIPS DUE TO LEG LENGTH DISCREPANCY, FOURTEEN (14) HIPS DUE TO MALPOSITION, EIGHT (8) HIPS DUE TO IMPLANT BREAKAGE STEM, SIX (6) HIPS DUE TO METAL RELATED PATHOLOGY, THREE (3) HIPS DUE TO WEAR OF ACETABULAR INSERT, THREE (3) HIPS DUE TO IMPLANT BREAKAGE ACETABULAR INSERT, ONE (1) HIP DUE TO IMPLANT BREAKAGE ACETABULAR, THREE (3) HIPS DUE TO INCORRECT SIZING, TEN (10) HIPS DUE TO WEAR HEAD, ONE (1) HIP DUE TO TUMOUR, AND SEVEN (7) HIPS DUE TO OTHER REASONS. - OXINIUM FEMORAL HEAD: A TOTAL OF FORTY-EIGHT THOUSAND THREE HUNDRED AND FIFTY-THREE (48,353) HIPS UNDERWENT PRIMARY THR BETWEEN 21-JAN-2003 AND 02 DEC-2025 IN WHICH AN OXINIUM FEMORAL HEAD WAS IMPLANTED. OF THESE, A TOTAL OF ONE THOUSAND SIX HUNDRED AND EIGHTY-FIVE (1,685) HIPS REQUIRED REVISION SURGERY. THIS TOTAL INCLUDES IMPLANTS APPROVED FOR USE IN THE UNITED STATES UNDER FDA PRODUCT CODES JDI AND LZO. OF THE ONE THOUSAND SIX HUNDRED AND EIGHTY-FIVE (1,685) REVISION SURGERIES REPORTED FOR THESE IMPLANTS, NINE HUNDRED AND FOUR (904) REVISIONS WERE ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED AN OXINIUM FEMORAL HEAD APPROVED UNDER FDA PRODUCT CODE LZO. THE AOANJRR REPORT PROVIDES THE COMPLETE LIST OF REASONS FOR REVISION FOR ALL 1,685 REVISION CASES BUT DOES NOT DISTINGUISH WHICH REASONS ARE SPECIFICALLY LINKED TO REVISION SURGERIES INVOLVING COMPONENTS APPROVED UNDER FDA PRODUCT CODE LZO. THE REPORTED REASONS FOR REVISION INCLUDE: THREE HUNDRED SEVENTY-ONE (371) DUE TO FRACTURE, TWO HUNDRED SIXTY (260) DUE TO LOOSENING, FOUR HUNDRED ELEVEN (411) DUE TO INFECTION, FOUR HUNDRED THREE (403) DUE TO PROSTHESIS DISLOCATION, THIRTY-TWO (32) DUE TO LYSIS, TWENTY-FOUR (24) DUE TO PAIN, FORTY (40) DUE TO INSTABILITY, TWENTY-NINE (29) DUE TO LEG LENGTH DISCREPANCY, THIRTY-ONE (31) DUE TO MALPOSITION, THIRTEEN (13) DUE TO IMPLANT BREAKAGE STEM, ONE (1) DUE TO METAL RELATED PATHOLOGY, SIXTEEN (16) DUE TO WEAR ACETABULAR INSERT, TWO (2) DUE TO IMPLANT BREAKAGE ACETABULAR INSERT, FOUR (4) DUE TO IMPLANT BREAKAGE ACETABULAR, EIGHT (8) DUE TO INCORRECT SIZING, THREE (3) DUE TO TUMOUR, SIX (6) DUE TO HETEROTOPIC BONE, ONE (1) DUE TO WEAR ACETABULUM, AND THIRTY (30) DUE TO OTHER REASONS. IN CONSIDERATION OF THE ABOVE, THE ANALYSIS CONDUCTED ON THE AOANJRR REGISTRY REPORT ENCOMPASSES ALL 1,685 REVISION SURGERIES REPORTED FOR THIS PRODUCT FAMILY. HOWEVER, THE .CSV FILE SUBMITTED UNDER THE REQUIREMENTS OF RWD2300584 INCLUDES ONLY 904 REVISIONS ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED AN OXINIUM FEMORAL HEAD APPROVED UNDER FDA PRODUCT CODE LZO. DUE TO THE STRUCTURE OF AOANJRR REPORT, IT IS NOT POSSIBLE TO ISOLATE OR ATTRIBUTE SPECIFIC STATISTICAL OUTCOMES OR REASONS FOR REVISION EXCLUSIVELY TO THE SUBSET OF 904 CASES. 2. PRIMARY HIP HEMI-ARTHROPLASTY: - OXINIUM FEMORAL HEAD: A TOTAL OF TWO HUNDRED AND TWENTY-EIGHT (228) HIPS UNDERWENT PRIMARY HIP HEMIARTHROPLASTY BETWEEN 02-SEP-2003 AND 29-OCT-2025 IN WHICH AN OXINIUM FEMORAL HEAD WAS IMPLANTED. OF THESE, A TOTAL OF SEVEN (7) HIPS REQUIRED REVISION DUE TO THE FOLLOWING REASONS: THREE (3) HIPS DUE TO PROSTHESIS DISLOCATION, TWO (2) HIPS DUE TO FRACTURE, ONE (1) HIP DUE TO CHONDROLYSIS/ACETABULAR EROSION, AND ONE (1) HIP DUE TO PAIN. DUE TO THE STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DIRECTLY CORRELATED WITH THE INDIVIDUAL PART NUMBERS REPORTED. AS SUCH, IT IS NOT POSSIBLE TO DETERMINE WHICH SPECIFIC PART NUMBERS WERE ASSOCIATED WITH WHICH SPECIFIC REASONS FOR REVISION. ALTOGETHER, A TOTAL QUANTITY OF 1293 REVISIONS BEEN REPORTED IN THE AUSTRALIA ORTHOPEDIC ASSOCIATION NATIONAL JOINT REPLACEMENT REGISTRY (AOANJRR)FOR THE SMITH+NEPHEW DEVICES REFERENCED IN THIS REPORT.

Description of Event or Problem · 0

Unique Complaint ID Number,Event Date,Date Entered,Manufacturer Aware Date,Brand Name,Generic Name,Model Number,Lot Number,Catalog Number,Serial Number,UDI Number,PMA / 510K Number,Date Returned to Manufacturer,Type of Reportable Event,Event Description,Manufacturer Narrative,Medical History,Patient Age,Patient Gender,Patient Weight,Date Implanted,Date Explanted,Health Effect Clinical Code,Health Effect Impact Code,Device Problem Code,Device Component Code,Investigation Type Code,Investigation Findings Code,Investigation Conclusion Code,Remedial Action Type,Latest Line Item Version;CASE-2026-00309786-1-L1,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 XL / +12,76539153,,76539153,,03596010540904,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L2,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 XL / +12,76539153,,76539153,,03596010540904,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L3,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 XL / +12,76539153,,76539153,,03596010540904,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L4,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 XL / +12,76539153,,76539153,,03596010540904,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L5,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 XL / +12,76539153,,76539153,,03596010540904,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L6,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 XL / +12,76539153,,76539153,,03596010540904,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L7,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 XL / +12,76539153,,76539153,,03596010540904,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L8,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 XL / +12,76539153,,76539153,,03596010540904,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L9,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 XL / +12,76539153,,76539153,,03596010540904,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L10,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 XL / +12,76539153,,76539153,,03596010540904,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L11,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 XL / +12,76539153,,76539153,,03596010540904,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L12,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 XL / +12,76539153,,76539153,,03596010540904,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L13,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 XL / +12,76539153,,76539153,,03596010540904,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L14,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 XL / +12,76539153,,76539153,,03596010540904,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L15,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 XL / +12,76539153,,76539153,,03596010540904,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L16,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 XL / +12,76539153,,76539153,,03596010540904,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L17,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,,76539160,,03596010566928,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L18,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,,76539160,,03596010566928,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L19,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,,76539160,,03596010566928,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L20,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,,76539160,,03596010566928,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L21,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,,76539160,,03596010566928,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L22,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,,76539160,,03596010566928,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L23,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,,76539160,,03596010566928,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L24,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,,76539160,,03596010566928,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L25,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,,76539160,,03596010566928,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L26,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,,76539160,,03596010566928,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L27,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,,76539160,,03596010566928,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L28,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,,76539160,,03596010566928,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L29,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,,76539160,,03596010566928,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L30,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,,76539160,,03596010566928,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L31,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,,76539160,,03596010566928,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L32,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,,76539160,,03596010566928,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L33,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,,76539160,,03596010566928,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L34,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,,76539160,,03596010566928,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L35,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,,76539160,,03596010566928,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L36,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,,76539160,,03596010566928,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L37,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,,76539160,,03596010566928,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L38,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,,76539160,,03596010566928,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L39,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,,76539160,,03596010566928,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L40,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,,76539160,,03596010566928,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L41,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,,76539160,,03596010566928,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L42,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,,76539160,,03596010566928,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L43,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,,76539160,,03596010566928,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L44,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,,76539160,,03596010566928,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L45,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,,76539160,,03596010566928,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L46,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,,76539160,,03596010566928,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L47,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,,76539160,,03596010566928,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L48,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,,76539160,,03596010566928,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L49,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,,76539160,,03596010566928,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L50,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,,76539160,,03596010566928,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L51,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,,76539160,,03596010566928,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L52,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,,76539160,,03596010566928,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L53,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,,76539160,,03596010566928,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L54,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,,76539160,,03596010566928,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L55,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,,76539160,,03596010566928,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L56,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,,76539160,,03596010566928,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L57,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,,76539160,,03596010566928,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L58,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,,76539160,,03596010566928,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L59,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,,76539160,,03596010566928,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L60,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 MEDIUM / +4,76539161,,76539161,,03596010566935,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L61,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 MEDIUM / +4,76539161,,76539161,,03596010566935,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L62,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 MEDIUM / +4,76539161,,76539161,,03596010566935,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L63,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 MEDIUM / +4,76539161,,76539161,,03596010566935,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L64,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 MEDIUM / +4,76539161,,76539161,,03596010566935,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L65,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 MEDIUM / +4,76539161,,76539161,,03596010566935,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L66,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 MEDIUM / +4,76539161,,76539161,,03596010566935,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L67,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 MEDIUM / +4,76539161,,76539161,,03596010566935,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L68,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 MEDIUM / +4,76539161,,76539161,,03596010566935,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L69,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 MEDIUM / +4,76539161,,76539161,,03596010566935,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L70,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 MEDIUM / +4,76539161,,76539161,,03596010566935,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L71,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 MEDIUM / +4,76539161,,76539161,,03596010566935,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L72,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 MEDIUM / +4,76539161,,76539161,,03596010566935,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L73,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 MEDIUM / +4,76539161,,76539161,,03596010566935,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L74,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 MEDIUM / +4,76539161,,76539161,,03596010566935,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L75,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 MEDIUM / +4,76539161,,76539161,,03596010566935,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L76,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 MEDIUM / +4,76539161,,76539161,,03596010566935,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L77,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 MEDIUM / +4,76539161,,76539161,,03596010566935,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L78,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 MEDIUM / +4,76539161,,76539161,,03596010566935,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L79,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 MEDIUM / +4,76539161,,76539161,,03596010566935,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L80,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 MEDIUM / +4,76539161,,76539161,,03596010566935,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L81,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 MEDIUM / +4,76539161,,76539161,,03596010566935,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L82,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 MEDIUM / +4,76539161,,76539161,,03596010566935,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L83,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 MEDIUM / +4,76539161,,76539161,,03596010566935,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L84,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 MEDIUM / +4,76539161,,76539161,,03596010566935,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L85,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 MEDIUM / +4,76539161,,76539161,,03596010566935,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L86,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 MEDIUM / +4,76539161,,76539161,,03596010566935,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L87,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 MEDIUM / +4,76539161,,76539161,,03596010566935,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L88,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 MEDIUM / +4,76539161,,76539161,,03596010566935,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L89,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 MEDIUM / +4,76539161,,76539161,,03596010566935,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L90,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 MEDIUM / +4,76539161,,76539161,,03596010566935,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L91,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 MEDIUM / +4,76539161,,76539161,,03596010566935,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L92,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 MEDIUM / +4,76539161,,76539161,,03596010566935,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L93,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 MEDIUM / +4,76539161,,76539161,,03596010566935,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L94,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 MEDIUM / +4,76539161,,76539161,,03596010566935,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L95,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 MEDIUM / +4,76539161,,76539161,,03596010566935,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L96,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 MEDIUM / +4,76539161,,76539161,,03596010566935,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L97,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 MEDIUM / +4,76539161,,76539161,,03596010566935,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L98,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 MEDIUM / +4,76539161,,76539161,,03596010566935,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L99,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 MEDIUM / +4,76539161,,76539161,,03596010566935,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L100,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 LONG /+8,76539162,,76539162,,03596010566942,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L101,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 LONG /+8,76539162,,76539162,,03596010566942,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L102,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 LONG /+8,76539162,,76539162,,03596010566942,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L103,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 LONG /+8,76539162,,76539162,,03596010566942,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L104,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 LONG /+8,76539162,,76539162,,03596010566942,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L105,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 LONG /+8,76539162,,76539162,,03596010566942,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L106,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 LONG /+8,76539162,,76539162,,03596010566942,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L107,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 32 MM 12/14 LONG /+8,76539162,,76539162,,03596010566942,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L108,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L109,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L110,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L111,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L112,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L113,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L114,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L115,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L116,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L117,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L118,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L119,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L120,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L121,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L122,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L123,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L124,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L125,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L126,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L127,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L128,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L129,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L130,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L131,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L132,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L133,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L134,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L135,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L136,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L137,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L138,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L139,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L140,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L141,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L142,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L143,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L144,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L145,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L146,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L147,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L148,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L149,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L150,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L151,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L152,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L153,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L154,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L155,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L156,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L157,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L158,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L159,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L160,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L161,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L162,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L163,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L164,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L165,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L166,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L167,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L168,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L169,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L170,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L171,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L172,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L173,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L174,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L175,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L176,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L177,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L178,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L179,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L180,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L181,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L182,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L183,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L184,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L185,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L186,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L187,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L188,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L189,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L190,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L191,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L192,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L193,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L194,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L195,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L196,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L197,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L198,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L199,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L200,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L201,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L202,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L203,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L204,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L205,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L206,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L207,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L208,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L209,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L210,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L211,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L212,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L213,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L214,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L215,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L216,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L217,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L218,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L219,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L220,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L221,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L222,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L223,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L224,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L225,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L226,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L227,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L228,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L229,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L230,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L231,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L232,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L233,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L234,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L235,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L236,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L237,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L238,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L239,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L240,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L241,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L242,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L243,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L244,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L245,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L246,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L247,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L248,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L249,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L250,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L251,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L252,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L253,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L254,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L255,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L256,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L257,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L258,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L259,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L260,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L261,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L262,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L263,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L264,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L265,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L266,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L267,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L268,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L269,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L270,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L271,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L272,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L273,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L274,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L275,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L276,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L277,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L278,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L279,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L280,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L281,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L282,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L283,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L284,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L285,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L286,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L287,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L288,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L289,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L290,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L291,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L292,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L293,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L294,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L295,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L296,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L297,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L298,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L299,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L300,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L301,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L302,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L303,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L304,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L305,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L306,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L307,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L308,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L309,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L310,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L311,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L312,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L313,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L314,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L315,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L316,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L317,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L318,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L319,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L320,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L321,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L322,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L323,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L324,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L325,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L326,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L327,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L328,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L329,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L330,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L331,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L332,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L333,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L334,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L335,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L336,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L337,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L338,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L339,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L340,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L341,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L342,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 LONG /+8,76539167,,76539167,,03596010566973,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L343,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 LONG /+8,76539167,,76539167,,03596010566973,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L344,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 LONG /+8,76539167,,76539167,,03596010566973,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L345,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 LONG /+8,76539167,,76539167,,03596010566973,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L346,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 LONG /+8,76539167,,76539167,,03596010566973,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L347,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 LONG /+8,76539167,,76539167,,03596010566973,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L348,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 LONG /+8,76539167,,76539167,,03596010566973,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L349,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 LONG /+8,76539167,,76539167,,03596010566973,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L350,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 LONG /+8,76539167,,76539167,,03596010566973,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L351,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 LONG /+8,76539167,,76539167,,03596010566973,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L352,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 LONG /+8,76539167,,76539167,,03596010566973,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L353,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 LONG /+8,76539167,,76539167,,03596010566973,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L354,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 LONG /+8,76539167,,76539167,,03596010566973,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L355,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 LONG /+8,76539167,,76539167,,03596010566973,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L356,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 LONG /+8,76539167,,76539167,,03596010566973,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L357,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 LONG /+8,76539167,,76539167,,03596010566973,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L358,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 LONG /+8,76539167,,76539167,,03596010566973,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L359,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 LONG /+8,76539167,,76539167,,03596010566973,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L360,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 LONG /+8,76539167,,76539167,,03596010566973,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L361,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 LONG /+8,76539167,,76539167,,03596010566973,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L362,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 LONG /+8,76539167,,76539167,,03596010566973,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L363,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 LONG /+8,76539167,,76539167,,03596010566973,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L364,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 LONG /+8,76539167,,76539167,,03596010566973,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L365,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 LONG /+8,76539167,,76539167,,03596010566973,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L366,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 LONG /+8,76539167,,76539167,,03596010566973,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L367,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 LONG /+8,76539167,,76539167,,03596010566973,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L368,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 LONG /+8,76539167,,76539167,,03596010566973,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L369,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 LONG /+8,76539167,,76539167,,03596010566973,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L370,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 LONG /+8,76539167,,76539167,,03596010566973,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L371,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 LONG /+8,76539167,,76539167,,03596010566973,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L372,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 LONG /+8,76539167,,76539167,,03596010566973,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L373,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 LONG /+8,76539167,,76539167,,03596010566973,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L374,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 LONG /+8,76539167,,76539167,,03596010566973,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L375,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 LONG /+8,76539167,,76539167,,03596010566973,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L376,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 LONG /+8,76539167,,76539167,,03596010566973,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L377,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 LONG /+8,76539167,,76539167,,03596010566973,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L378,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 LONG /+8,76539167,,76539167,,03596010566973,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L379,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 LONG /+8,76539167,,76539167,,03596010566973,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L380,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 LONG /+8,76539167,,76539167,,03596010566973,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L381,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 LONG /+8,76539167,,76539167,,03596010566973,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00309786-1-L382,,4/27/2026,2/10/2026,BIOLOX Delta,BIOLOX DELTA HEAD 36 MM 12/14 LONG /+8,76539167,,76539167,,03596010566973,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a BIOLOX Delta Ceramic Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted. Of these, three hundred and eighty-two (382) hips required revision due to the following reasons: eighty-two (82) hips due to fracture, seventy (70) hips due to loosening, sixty-seven (67) hips due to infection, seventy-one (71) hips due to prosthesis dislocation, six (6) hips due to lysis, twelve (12) hips due to pain, nine (9) hips due to instability, nine (9) hips due to leg length discrepancy, fourteen (14) hips due to malposition, eight (8) hips due to implant breakage stem, six (6) hips due to metal related pathology, three (3) hips due to wear of acetabular insert, three (3) hips due to implant breakage acetabular insert, one (1) hip due to implant breakage acetabular, three (3) hips due to incorrect sizing, ten (10) hips due to wear head, one (1) hip due to tumour, and seven (7) hips due to other reasons.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2006 and 20-Aug-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ten thousand five hundred and sixty-three (10,563) hips underwent primary THR in which a BIOLOX Delta Ceramic Femoral Head was implanted in Australia between 01-Feb-2006 and 20-Aug-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 1.5% (1.2%¿1.7%) vs 1.8% (1.7%¿1.8%) of the class.;? At 2nd post?operative year: 1.8% (1.5%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;? At 3rd post?operative year: 2.1% (1.8%¿2.4%) vs 2.6% (2.5%¿2.6%) of the class.;? At 4th post?operative year: 2.2% (2.0%¿2.6%) vs 2.9% (2.8%¿2.9%) of the class.;? At 5th post?operative year: 2.5% (2.2%¿2.8%) vs 3.2% (3.1%¿3.2%) of the class.;? At 6th post?operative year: 2.6% (2.3%¿2.9%) vs 3.5% (3.4%¿3.5%) of the class.;? At 7th post?operative year: 2.9% (2.6%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;? At 8th post?operative year: 3.2% (2.9%¿3.6%) vs 4.1% (4.0%¿4.1%) of the class.;? At 9th post?operative year: 3.5% (3.1%¿3.9%) vs 4.4% (4.4%¿4.5%) of the class.;? At 10th post?operative year: 3.6% (3.2%¿4.0%) vs 4.8% (4.7%¿4.8%) of the class.;? At 11th post?operative year: 3.9% (3.5%¿4.3%) vs 5.1% (5.1%¿5.2%) of the class.;? At 12th post?operative year: 4.1% (3.7%¿4.6%) vs 5.6% (5.5%¿5.7%) of the class.;? At 13th post?operative year: 4.3% (3.9%¿4.8%) vs 6.0% (5.9%¿6.1%) of the class.;? At 14th post?operative year: 4.5% (4.0%¿5.0%) vs 6.4% (6.3%¿6.5%) of the class.;? At 15th post?operative year: 4.7% (4.2%¿5.3%) vs 6.9% (6.8%¿7.0%) of the class.;? At 16th post?operative year: 5.2% (4.6%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;? At 17th post?operative year: 5.5% (4.7%¿6.3%) vs 7.9% (7.8%¿8.0%) of the class;By observing the cumulative revision rates above, it can be concluded that, at the 1st post?operative year, the BIOLOX Delta Ceramic Femoral Head is in line with the THR class based on overlapping 95% confidence intervals.;From the 2nd post?operative year onward the BIOLOX Delta Ceramic Femoral Head demonstrates statistically significantly lower revision rates than the THR class, as determined by non?overlapping 95% confidence intervals. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L1,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 22 MM +0,71342200,,71342200,,03596010488862,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L2,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 22 MM +0,71342200,,71342200,,03596010488862,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L3,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 22 MM +0,71342200,,71342200,,03596010488862,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L4,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 22 MM +0,71342200,,71342200,,03596010488862,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L5,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 22 MM +0,71342200,,71342200,,03596010488862,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L6,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 22 MM +0,71342200,,71342200,,03596010488862,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L7,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 22 MM +0,71342200,,71342200,,03596010488862,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L8,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 22 MM +0,71342200,,71342200,,03596010488862,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L9,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 22 MM +0,71342200,,71342200,,03596010488862,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L10,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 22 MM +4,71342204,,71342204,,03596010488879,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L11,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 22 MM +4,71342204,,71342204,,03596010488879,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L12,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L13,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L14,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L15,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L16,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L17,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L18,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L19,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L20,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L21,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L22,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L23,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L24,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L25,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L26,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L27,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L28,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L29,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L30,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L31,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L32,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L33,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L34,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L35,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L36,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L37,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L38,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L39,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L40,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L41,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L42,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L43,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L44,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L45,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L46,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L47,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L48,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L49,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L50,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L51,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L52,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L53,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L54,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L55,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L56,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L57,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L58,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L59,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L60,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L61,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L62,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L63,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L64,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L65,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L66,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L67,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L68,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L69,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L70,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L71,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L72,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L73,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L74,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L75,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L76,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L77,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L78,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L79,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L80,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L81,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L82,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L83,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L84,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L85,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L86,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L87,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L88,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L89,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L90,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L91,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L92,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L93,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L94,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L95,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L96,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L97,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L98,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L99,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L100,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L101,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L102,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L103,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L104,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L105,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L106,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L107,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L108,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L109,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L110,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L111,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L112,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L113,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L114,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L115,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L116,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L117,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L118,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L119,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L120,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L121,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L122,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L123,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L124,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L125,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L126,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L127,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L128,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L129,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L130,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L131,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L132,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L133,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L134,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L135,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L136,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L137,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L138,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L139,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L140,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L141,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L142,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L143,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L144,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L145,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L146,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L147,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L148,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L149,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L150,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L151,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L152,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L153,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L154,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L155,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L156,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L157,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L158,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L159,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L160,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L161,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L162,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L163,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L164,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L165,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L166,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L167,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L168,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L169,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L170,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L171,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L172,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L173,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L174,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L175,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L176,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L177,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L178,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L179,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L180,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L181,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L182,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L183,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L184,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L185,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L186,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L187,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L188,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L189,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L190,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L191,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L192,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L193,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L194,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L195,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L196,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L197,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L198,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L199,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L200,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L201,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L202,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L203,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L204,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L205,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L206,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L207,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L208,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L209,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L210,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L211,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L212,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L213,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L214,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L215,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L216,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L217,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L218,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L219,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L220,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L221,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L222,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L223,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L224,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L225,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L226,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L227,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L228,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L229,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L230,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L231,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L232,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L233,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L234,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L235,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L236,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L237,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L238,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L239,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L240,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L241,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L242,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L243,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L244,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L245,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L246,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L247,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L248,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L249,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L250,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L251,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +8,71342808,,71342808,,03596010474179,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L252,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +8,71342808,,71342808,,03596010474179,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L253,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +8,71342808,,71342808,,03596010474179,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L254,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +8,71342808,,71342808,,03596010474179,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L255,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +8,71342808,,71342808,,03596010474179,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L256,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +8,71342808,,71342808,,03596010474179,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L257,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +8,71342808,,71342808,,03596010474179,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L258,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +8,71342808,,71342808,,03596010474179,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L259,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +8,71342808,,71342808,,03596010474179,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L260,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +8,71342808,,71342808,,03596010474179,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L261,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +8,71342808,,71342808,,03596010474179,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L262,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +8,71342808,,71342808,,03596010474179,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L263,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +8,71342808,,71342808,,03596010474179,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L264,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +8,71342808,,71342808,,03596010474179,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L265,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +12,71342812,,71342812,,03596010474186,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L266,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +12,71342812,,71342812,,03596010474186,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L267,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +12,71342812,,71342812,,03596010474186,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L268,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +12,71342812,,71342812,,03596010474186,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L269,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +12,71342812,,71342812,,03596010474186,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L270,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L271,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L272,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L273,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L274,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L275,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L276,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L277,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L278,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L279,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L280,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L281,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L282,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L283,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L284,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L285,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L286,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L287,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L288,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L289,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L290,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L291,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L292,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L293,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L294,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L295,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L296,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L297,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L298,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L299,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L300,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L301,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L302,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L303,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L304,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L305,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L306,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L307,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L308,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L309,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L310,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L311,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L312,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L313,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L314,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L315,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L316,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L317,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L318,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L319,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L320,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L321,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L322,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L323,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L324,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L325,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L326,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L327,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L328,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L329,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L330,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L331,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L332,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L333,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L334,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L335,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L336,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L337,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L338,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L339,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L340,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L341,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L342,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L343,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L344,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L345,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L346,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L347,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L348,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L349,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L350,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L351,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L352,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L353,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L354,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L355,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L356,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L357,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L358,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L359,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L360,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L361,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L362,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L363,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L364,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L365,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L366,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L367,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L368,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L369,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L370,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L371,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L372,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L373,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L374,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L375,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L376,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L377,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L378,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L379,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L380,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L381,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L382,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L383,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L384,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L385,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L386,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L387,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L388,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L389,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L390,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L391,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L392,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L393,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L394,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L395,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L396,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L397,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L398,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L399,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L400,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L401,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L402,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L403,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L404,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L405,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L406,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L407,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L408,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L409,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L410,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L411,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L412,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L413,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L414,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L415,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L416,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L417,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L418,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L419,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L420,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L421,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L422,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L423,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L424,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L425,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L426,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L427,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L428,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L429,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L430,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L431,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L432,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L433,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L434,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L435,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L436,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L437,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L438,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L439,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L440,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L441,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L442,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L443,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L444,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L445,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L446,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L447,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L448,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L449,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L450,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L451,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L452,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L453,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L454,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L455,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L456,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L457,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L458,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L459,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L460,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L461,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L462,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L463,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L464,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L465,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L466,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L467,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L468,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L469,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L470,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L471,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L472,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L473,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L474,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L475,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L476,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L477,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L478,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L479,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L480,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L481,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L482,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L483,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L484,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L485,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L486,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L487,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L488,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L489,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L490,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L491,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L492,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L493,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L494,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L495,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L496,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L497,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L498,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L499,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L500,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L501,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L502,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L503,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L504,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L505,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L506,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L507,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L508,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L509,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L510,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L511,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L512,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L513,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L514,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L515,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L516,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L517,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L518,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L519,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L520,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L521,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L522,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L523,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L524,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L525,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L526,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L527,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L528,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L529,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L530,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L531,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L532,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L533,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L534,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L535,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L536,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L537,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L538,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L539,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L540,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L541,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L542,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L543,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L544,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L545,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L546,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L547,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L548,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L549,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L550,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L551,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L552,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L553,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L554,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L555,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L556,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L557,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L558,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L559,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L560,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L561,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L562,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L563,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L564,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L565,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L566,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L567,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L568,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L569,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L570,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L571,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L572,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L573,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L574,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L575,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L576,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L577,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L578,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L579,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L580,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L581,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L582,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L583,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L584,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L585,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L586,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L587,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L588,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L589,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L590,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L591,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L592,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L593,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L594,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L595,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L596,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L597,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L598,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L599,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L600,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L601,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L602,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L603,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L604,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L605,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L606,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L607,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L608,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L609,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L610,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L611,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L612,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L613,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L614,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L615,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L616,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L617,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L618,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L619,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L620,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L621,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L622,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L623,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L624,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L625,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L626,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L627,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L628,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L629,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L630,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L631,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L632,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L633,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L634,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L635,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L636,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L637,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L638,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L639,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L640,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L641,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L642,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L643,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L644,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L645,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L646,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L647,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L648,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L649,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L650,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L651,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L652,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L653,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L654,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L655,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L656,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L657,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L658,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L659,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L660,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L661,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L662,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L663,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L664,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L665,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L666,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L667,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L668,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L669,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L670,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L671,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L672,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L673,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L674,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L675,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L676,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L677,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L678,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L679,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L680,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L681,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L682,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L683,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L684,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L685,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L686,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L687,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L688,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L689,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L690,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L691,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L692,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L693,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L694,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L695,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L696,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L697,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L698,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L699,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L700,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L701,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L702,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L703,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L704,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L705,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L706,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L707,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L708,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L709,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L710,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L711,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L712,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L713,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L714,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L715,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L716,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L717,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L718,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L719,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L720,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L721,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L722,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L723,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L724,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L725,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L726,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L727,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L728,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L729,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L730,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L731,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L732,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L733,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L734,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L735,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L736,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L737,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L738,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L739,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L740,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L741,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L742,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L743,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L744,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L745,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L746,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L747,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L748,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L749,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L750,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L751,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L752,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L753,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L754,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L755,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L756,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L757,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L758,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L759,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L760,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L761,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L762,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L763,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L764,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L765,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L766,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L767,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L768,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L769,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L770,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L771,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L772,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L773,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L774,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L775,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L776,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L777,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L778,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L779,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L780,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L781,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L782,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L783,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L784,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L785,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L786,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L787,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L788,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L789,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L790,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L791,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L792,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L793,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L794,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L795,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L796,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L797,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L798,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L799,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L800,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L801,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L802,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L803,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L804,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L805,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L806,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L807,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L808,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L809,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L810,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L811,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L812,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L813,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L814,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L815,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L816,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L817,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L818,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L819,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L820,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L821,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L822,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L823,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L824,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L825,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L826,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L827,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L828,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L829,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L830,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L831,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L832,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L833,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L834,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L835,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L836,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L837,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L838,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L839,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L840,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L841,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L842,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L843,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L844,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L845,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L846,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L847,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L848,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L849,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L850,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L851,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L852,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L853,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L854,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L855,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L856,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L857,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L858,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L859,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L860,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L861,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L862,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L863,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L864,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L865,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L866,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L867,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L868,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L869,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L870,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L871,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32 MM +12,71343212,,71343212,,03596010516275,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L872,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32 MM +12,71343212,,71343212,,03596010516275,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L873,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32 MM +12,71343212,,71343212,,03596010516275,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L874,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32 MM +12,71343212,,71343212,,03596010516275,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L875,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32 MM +12,71343212,,71343212,,03596010516275,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L876,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32 MM +12,71343212,,71343212,,03596010516275,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L877,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32 MM +16,71343216,,71343216,,03596010525185,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L878,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 32 MM +16,71343216,,71343216,,03596010525185,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L879,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM XL/+12,71343612,,71343612,,03596010520449,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L880,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM XL/+12,71343612,,71343612,,03596010520449,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L881,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM XL/+12,71343612,,71343612,,03596010520449,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L882,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM XL/+12,71343612,,71343612,,03596010520449,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L883,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM XL/+12,71343612,,71343612,,03596010520449,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L884,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM XL/+12,71343612,,71343612,,03596010520449,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L885,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM XL/+12,71343612,,71343612,,03596010520449,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L886,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM XL/+12,71343612,,71343612,,03596010520449,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L887,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM XL/+12,71343612,,71343612,,03596010520449,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L888,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM XL/+12,71343612,,71343612,,03596010520449,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L889,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM XL/+12,71343612,,71343612,,03596010520449,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L890,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM XL/+12,71343612,,71343612,,03596010520449,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L891,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM XL/+12,71343612,,71343612,,03596010520449,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L892,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM XL/+12,71343612,,71343612,,03596010520449,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L893,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM XL/+12,71343612,,71343612,,03596010520449,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L894,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM XL/+12,71343612,,71343612,,03596010520449,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L895,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM XL/+12,71343612,,71343612,,03596010520449,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L896,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM XL/+12,71343612,,71343612,,03596010520449,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L897,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM XL/+12,71343612,,71343612,,03596010520449,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L898,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM XL/+12,71343612,,71343612,,03596010520449,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L899,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM XL/+12,71343612,,71343612,,03596010520449,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L900,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM XL/+12,71343612,,71343612,,03596010520449,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L901,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM XL/+12,71343612,,71343612,,03596010520449,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L902,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM XL/+12,71343612,,71343612,,03596010520449,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L903,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM XL/+12,71343612,,71343612,,03596010520449,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310127-1-L904,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM XL/+12,71343612,,71343612,,03596010520449,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which an Oxinium Femoral Head implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted. Of these, one thousand six hundred and eighty-five (1,685) hips required revision surgery. This total includes implants approved for use in the United States under FDA product codes JDI and LZO. Of the one thousand six hundred and eighty-five (1,685) revision surgeries reported for these implants, nine hundred and four (904) revisions were associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO.;The AOANJRR report provides the complete list of reasons for revision for all 1,685 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code LZO. The reported reasons for revision include: three hundred seventy-one (371) due to fracture, two hundred sixty (260) due to loosening, four hundred eleven (411) due to infection, four hundred three (403) due to prosthesis dislocation, thirty-two (32) due to lysis, twenty-four (24) due to pain, forty (40) due to instability, twenty-nine (29) due to leg length discrepancy, thirty-one (31) due to malposition, thirteen (13) due to implant breakage stem, one (1) due to metal related pathology, sixteen (16) due to wear acetabular insert, two (2) due to implant breakage acetabular insert, four (4) due to implant breakage acetabular, eight (8) due to incorrect sizing, three (3) due to tumour, six (6) due to heterotopic bone, one (1) due to wear acetabulum, and thirty (30) due to other reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,685 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 904 associated with hips that had previously received an Oxinium Femoral Head approved under FDA product code LZO. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 904 cases. In addition, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 21-Jan-2003 and 02 Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-eight thousand three hundred and fifty-three (48,353) hips underwent primary THR in which an Oxinium Femoral Head was implanted in Australia between 21-Jan-2003 and 02 Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.9% (1.8%¿2.0%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 2.2% (2.1%¿2.4%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 2.5% (2.3%¿2.6%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.7% (2.6%¿2.9%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.9% (2.8%¿3.1%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 3.1% (3.0%¿3.3%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.3% (3.1%¿3.5%) vs 3.8% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.5% (3.3%¿3.7%) vs 4.1% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 3.8% (3.6%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;- At 10th post-operative year: 4.0% (3.8%¿4.2%) vs 4.8% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 4.2% (4.0%¿4.5%) vs 5.1% (5.1%¿5.2%) of the class.;- At 12th post-operative year: 4.5% (4.2%¿4.7%) vs 5.6% (5.5%¿5.6%) of the class.;- At 13th post-operative year: 4.8% (4.5%¿5.1%) vs 6.0% (5.9%¿6.1%) of the class.;- At 14th post-operative year: 5.0% (4.8%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;- At 15th post-operative year: 5.3% (5.0%¿5.6%) vs 6.9% (6.8%¿7.0%) of the class.;- At 16th post-operative year: 5.6% (5.3%¿6.0%) vs 7.4% (7.3%¿7.5%) of the class.;- At 17th post-operative year: 5.9% (5.5%¿6.3%) vs 7.8% (7.7%¿8.0%) of the class.;- At 18th post-operative year: 6.1% (5.7%¿6.5%) vs 8.3% (8.2%¿8.5%) of the class.;- At 19th post-operative year: 6.5% (6.0%¿7.1%) vs 8.8% (8.7%¿9.0%) of the class.;- At 20th post-operative year: 6.9% (6.3%¿7.5%) vs 9.3% (9.2%¿9.5%) of the class.;- At 21st post-operative year: 7.1% (6.4%¿7.8%) vs 9.8% (9.7%¿10.0%) of the class.;- At 22nd post-operative year: 7.1% (6.4%¿7.8%) vs 10.3% (10.1%¿10.5%) of the class;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Oxinium Femoral Head and the THR class revision rates during the first five post?operative years, as determined by overlapping 95% confidence intervals.;From the 6th post?operative year onward, the 95% confidence intervals do not overlap, indicating a statistically significant difference, with lower cumulative revision rates for the Oxinium Femoral Head compared to the THR class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310547-1-L1,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary hip hemiarthroplasty in which an Oxinium Femoral Head was implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of two hundred and twenty-eight (228) hips underwent primary hip hemiarthroplasty in which a Oxinium Femoral Head was implanted. Of these, seven (7) hips required revision due to the following reasons: three (3) hips due to prosthesis dislocation, two (2) hips due to fracture, one (1) hip due to chondrolysis/acetabular erosion, and one (1) hip due to pain. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 02-Sep-2003 and 29-Oct-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two hundred and twenty-eight (228) hips underwent primary hip hemiarthroplasty in which an Oxinium Femoral Head was implanted in Australia between 02-Sep-2003 and 29-Oct-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 2.1% (0.8%¿5.5%) vs 2.4% (2.3%¿2.6%) of the class.;? At 2nd post?operative year: 2.1% (0.8%¿5.5%) vs 3.1% (2.9%¿3.2%) of the class.;? At 3rd post?operative year: 3.1% (1.2%¿7.9%) vs 3.5% (3.3%¿3.7%) of the class.;? At 4th post?operative year: 4.7% (1.9%¿11.4%) vs 3.8% (3.6%¿4.0%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference in revision rates between the Oxinium Femoral Head and the Primary Hip Hemiarthroplasty class (Other Bipolar Hip) during the first four post?operative years, as determined by overlapping 95% confidence intervals at each follow-up year. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310547-1-L2,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary hip hemiarthroplasty in which an Oxinium Femoral Head was implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of two hundred and twenty-eight (228) hips underwent primary hip hemiarthroplasty in which a Oxinium Femoral Head was implanted. Of these, seven (7) hips required revision due to the following reasons: three (3) hips due to prosthesis dislocation, two (2) hips due to fracture, one (1) hip due to chondrolysis/acetabular erosion, and one (1) hip due to pain. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 02-Sep-2003 and 29-Oct-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two hundred and twenty-eight (228) hips underwent primary hip hemiarthroplasty in which an Oxinium Femoral Head was implanted in Australia between 02-Sep-2003 and 29-Oct-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 2.1% (0.8%¿5.5%) vs 2.4% (2.3%¿2.6%) of the class.;? At 2nd post?operative year: 2.1% (0.8%¿5.5%) vs 3.1% (2.9%¿3.2%) of the class.;? At 3rd post?operative year: 3.1% (1.2%¿7.9%) vs 3.5% (3.3%¿3.7%) of the class.;? At 4th post?operative year: 4.7% (1.9%¿11.4%) vs 3.8% (3.6%¿4.0%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference in revision rates between the Oxinium Femoral Head and the Primary Hip Hemiarthroplasty class (Other Bipolar Hip) during the first four post?operative years, as determined by overlapping 95% confidence intervals at each follow-up year. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310547-1-L3,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,,71342803,,03596010474155,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary hip hemiarthroplasty in which an Oxinium Femoral Head was implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of two hundred and twenty-eight (228) hips underwent primary hip hemiarthroplasty in which a Oxinium Femoral Head was implanted. Of these, seven (7) hips required revision due to the following reasons: three (3) hips due to prosthesis dislocation, two (2) hips due to fracture, one (1) hip due to chondrolysis/acetabular erosion, and one (1) hip due to pain. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 02-Sep-2003 and 29-Oct-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two hundred and twenty-eight (228) hips underwent primary hip hemiarthroplasty in which an Oxinium Femoral Head was implanted in Australia between 02-Sep-2003 and 29-Oct-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 2.1% (0.8%¿5.5%) vs 2.4% (2.3%¿2.6%) of the class.;? At 2nd post?operative year: 2.1% (0.8%¿5.5%) vs 3.1% (2.9%¿3.2%) of the class.;? At 3rd post?operative year: 3.1% (1.2%¿7.9%) vs 3.5% (3.3%¿3.7%) of the class.;? At 4th post?operative year: 4.7% (1.9%¿11.4%) vs 3.8% (3.6%¿4.0%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference in revision rates between the Oxinium Femoral Head and the Primary Hip Hemiarthroplasty class (Other Bipolar Hip) during the first four post?operative years, as determined by overlapping 95% confidence intervals at each follow-up year. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310547-1-L4,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary hip hemiarthroplasty in which an Oxinium Femoral Head was implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of two hundred and twenty-eight (228) hips underwent primary hip hemiarthroplasty in which a Oxinium Femoral Head was implanted. Of these, seven (7) hips required revision due to the following reasons: three (3) hips due to prosthesis dislocation, two (2) hips due to fracture, one (1) hip due to chondrolysis/acetabular erosion, and one (1) hip due to pain. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 02-Sep-2003 and 29-Oct-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two hundred and twenty-eight (228) hips underwent primary hip hemiarthroplasty in which an Oxinium Femoral Head was implanted in Australia between 02-Sep-2003 and 29-Oct-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 2.1% (0.8%¿5.5%) vs 2.4% (2.3%¿2.6%) of the class.;? At 2nd post?operative year: 2.1% (0.8%¿5.5%) vs 3.1% (2.9%¿3.2%) of the class.;? At 3rd post?operative year: 3.1% (1.2%¿7.9%) vs 3.5% (3.3%¿3.7%) of the class.;? At 4th post?operative year: 4.7% (1.9%¿11.4%) vs 3.8% (3.6%¿4.0%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference in revision rates between the Oxinium Femoral Head and the Primary Hip Hemiarthroplasty class (Other Bipolar Hip) during the first four post?operative years, as determined by overlapping 95% confidence intervals at each follow-up year. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310547-1-L5,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary hip hemiarthroplasty in which an Oxinium Femoral Head was implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of two hundred and twenty-eight (228) hips underwent primary hip hemiarthroplasty in which a Oxinium Femoral Head was implanted. Of these, seven (7) hips required revision due to the following reasons: three (3) hips due to prosthesis dislocation, two (2) hips due to fracture, one (1) hip due to chondrolysis/acetabular erosion, and one (1) hip due to pain. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 02-Sep-2003 and 29-Oct-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two hundred and twenty-eight (228) hips underwent primary hip hemiarthroplasty in which an Oxinium Femoral Head was implanted in Australia between 02-Sep-2003 and 29-Oct-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 2.1% (0.8%¿5.5%) vs 2.4% (2.3%¿2.6%) of the class.;? At 2nd post?operative year: 2.1% (0.8%¿5.5%) vs 3.1% (2.9%¿3.2%) of the class.;? At 3rd post?operative year: 3.1% (1.2%¿7.9%) vs 3.5% (3.3%¿3.7%) of the class.;? At 4th post?operative year: 4.7% (1.9%¿11.4%) vs 3.8% (3.6%¿4.0%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference in revision rates between the Oxinium Femoral Head and the Primary Hip Hemiarthroplasty class (Other Bipolar Hip) during the first four post?operative years, as determined by overlapping 95% confidence intervals at each follow-up year. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310547-1-L6,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary hip hemiarthroplasty in which an Oxinium Femoral Head was implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of two hundred and twenty-eight (228) hips underwent primary hip hemiarthroplasty in which a Oxinium Femoral Head was implanted. Of these, seven (7) hips required revision due to the following reasons: three (3) hips due to prosthesis dislocation, two (2) hips due to fracture, one (1) hip due to chondrolysis/acetabular erosion, and one (1) hip due to pain. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 02-Sep-2003 and 29-Oct-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two hundred and twenty-eight (228) hips underwent primary hip hemiarthroplasty in which an Oxinium Femoral Head was implanted in Australia between 02-Sep-2003 and 29-Oct-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 2.1% (0.8%¿5.5%) vs 2.4% (2.3%¿2.6%) of the class.;? At 2nd post?operative year: 2.1% (0.8%¿5.5%) vs 3.1% (2.9%¿3.2%) of the class.;? At 3rd post?operative year: 3.1% (1.2%¿7.9%) vs 3.5% (3.3%¿3.7%) of the class.;? At 4th post?operative year: 4.7% (1.9%¿11.4%) vs 3.8% (3.6%¿4.0%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference in revision rates between the Oxinium Femoral Head and the Primary Hip Hemiarthroplasty class (Other Bipolar Hip) during the first four post?operative years, as determined by overlapping 95% confidence intervals at each follow-up year. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310547-1-L7,,4/27/2026,2/10/2026,OXINIUM,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary hip hemiarthroplasty in which an Oxinium Femoral Head was implanted, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of two hundred and twenty-eight (228) hips underwent primary hip hemiarthroplasty in which a Oxinium Femoral Head was implanted. Of these, seven (7) hips required revision due to the following reasons: three (3) hips due to prosthesis dislocation, two (2) hips due to fracture, one (1) hip due to chondrolysis/acetabular erosion, and one (1) hip due to pain. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 02-Sep-2003 and 29-Oct-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two hundred and twenty-eight (228) hips underwent primary hip hemiarthroplasty in which an Oxinium Femoral Head was implanted in Australia between 02-Sep-2003 and 29-Oct-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post?operative year: 2.1% (0.8%¿5.5%) vs 2.4% (2.3%¿2.6%) of the class.;? At 2nd post?operative year: 2.1% (0.8%¿5.5%) vs 3.1% (2.9%¿3.2%) of the class.;? At 3rd post?operative year: 3.1% (1.2%¿7.9%) vs 3.5% (3.3%¿3.7%) of the class.;? At 4th post?operative year: 4.7% (1.9%¿11.4%) vs 3.8% (3.6%¿4.0%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference in revision rates between the Oxinium Femoral Head and the Primary Hip Hemiarthroplasty class (Other Bipolar Hip) during the first four post?operative years, as determined by overlapping 95% confidence intervals at each follow-up year. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
26000		PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS	LZO	SMITH & NEPHEW, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1	65 YR	Unknown

Terms

Patient problem · 13

• Aseptic loosening
• Deformity/ Disfigurement
• Erosion
• Insufficient Information
• Joint Dislocation
• Joint Laxity
• Metal Related Pathology
• Osteolysis
• Pain
• Periprosthetic fracture
• Solid Tumour
• Unequal Limb Length
• Unspecified Infection

Product problems · 6

• Adverse Event Without Identified Device or Use Problem
• Fracture
• Improper or Incorrect Procedure or Method
• Malposition of Device
• Material Erosion
• Osseointegration Problem

Source type · 1

• Other

Type of report · 1

• Initial submission